System for caries management by risk assessment

ABSTRACT

The invention provides the tools needed for a dental patient&#39;s caries risk assessment. Included is a complete turnkey system for caries risk assessment and treatment, including an ATP test and a plurality of rinses and educational and diagnostic materials. The system for the detection and treatment of the bacterial infection that causes dental caries in a patient comprises a disposable ATP Bioluminescence sampler to swab areas of the patient&#39;s mouth, a bioluminescent light meter which measures the amount of ATP present in the patient&#39;s mouth, a rapid culture test for the detection of  Mutans streptococci  and  lactobacilli , a diagnostic testing component that includes a caries risk assessment questionnaire, a treatment component that includes a short term therapeutic oral rinse of at least two components, and a long term maintenance rinse.

RELATED PATENT APPLICATIONS & INCORPORATION BY REFERENCE

This application is a divisional application of U.S. application Ser.No. 11/337,435, entitled “System for Caries Management by RiskAssessment,” filed Jan. 23, 2006. This related application isincorporated herein by reference and made a part of this application.Moreover, any and all U.S. patents, U.S. patent applications, and otherdocuments, hard copy or electronic, cited or referred to in thisapplication are incorporated herein by reference and made a part of thisapplication.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to the prevention and treatment of dental caries,including risk assessment, activity level, intervention and materialsfor the measuring said risk. Advanced clinical treatment procedures,methods and materials are presented and claimed herein.

2. Background and Related Art

Dentistry is usually considered to involve the restoration of naturalteeth as they become carious. Cosmetic dentistry is another concept andan option with regard to tooth whitening and in some cases, orthodontia.In the July/August 2003 Dental Practice Report, Spaeth, in an articleentitled “Not your father's dentistry” quotes Dr. G. V. Black who said,in 1896, that someday dentists would be “engaged in practicingpreventive, rather than reparative, dentistry”.

These sentiments were echoed in 1997, when Dr. Harold Slavkin discussedbiological solutions to oral health problems including biologicalapproaches to restorative dentistry in the repair destroyed by infectionfrom Streptococcus mutans. There have been some patents that dealt withthe idea of bacterial causes of dental decay and other problems. Forexample, Miehl in U.S. Pat. No. 5,213,615 uses active agents; saidactive agents are applied to the teeth as a dental varnish, cement, andthe like. In RE 31,815 Alfano teaches a method for detecting thepresence of caries in the teeth by the use of light beams of certainwavelengths and comparing the ratio of intensities of the lights in aplurality of carious and non-carious lesions in the mouth.

The prior art mentioned above dealt with advanced ways and means of thedetection of carious areas of a patient's mouth. In U.S. Pat. No.5,738,113 Connelly is concerned with the control and reduction of dentalcaries in people who are at risk of dental caries. Connelly discusses amethod that applies fluoride and antimicrobial agents but does notprovide a complete system for caries management by risk assessment.

In US patent application 20050191247, Drake et al disclosesantimicrobial rinses and products based on chlorhexidine, alcohol free,xylitol and raspberry flavoring. Another US patent application20050169852, to Roberge et al, discusses antimicrobial rinses all basedon CPC, cetyl pyridium chloride.

US patent application 20050142074 to Pushpangadan et al is concernedwith antimicrobial rinses based on herbs and herbal root extracts. USpatent application number 20050100866 to Arnone et al shows anelectronic DC probe used to determine if decay is in a tooth based onelectric resistance.

In US patent application number 20050025720 Bailey shows a oralmaintenance kit based on xylitol products with gum, candy, rinse,toothpaste and the like. US patent application number 20020114768 byStoor et al discloses antimicrobial rinses based on essential oils.

U.S. Pat. No. 6,846,478 to Doyle et al discloses oral antimicrobialrinses based on chlorite ion. Applicants' invention utilizes thehypochlorite ion as an antibacterial agent in various embodiments, notthe chlorite ion. Applicants' invention comprises various rinses as wellas an important diagnostic component.

Dental caries recently has been considered as a complex, transmissiblebacterial infection. There are multiple pathogenic, cariogenic, bacteriainvolved in the dental caries process. Dentistry has identified a coupleof the specific bacterial pathogens, but many of the bacteria remainunidentified and not culturable in the laboratory. Consequently, thiscomplex process is not completely understood. Current scientificresearch is focusing not so much on the specific bacterial pathogens,but on the cariogenic bacterial biofilm that causes the disease, and theactivity potential of that biofilm.

In contrast to the previous inventions in the field, the currentinvention is looking for and detecting amounts and types of bacteria inthe mouth. This invention includes a plurality of screening tests forthe detection of Mutans streptococci and Lactobacilli in the patient'ssaliva and tooth surfaces. In addition to the levels of bacterialbiofilm and the activity and activity potential of the bacterial biofilmit is seen as a diagnostic measure of the patient's presence of and riskfor caries activity in their mouth. In this invention, one screeningtest is concerned with biofilm level in the mouth is determined byfinding and measuring adenosine triphosphate (ATP), the energy moleculeof living cells to measure the bioluminescence and to then correlate theamount of ATP present to the amount of bacterial load in the mouth.

The bacterial load in the mouth can also be measured with a secondscreening test, the protein detection screen; however, all teeth (evenhealthy teeth) are covered with a protective protein layer, thepellicle. The protein level as a determinant of the amount of bacterialbiofilm present must account for the average pellicle protein baselinereading. In this invention, the presence of bacteria at high risk levelscan be determined by a simple swab test looking for protein presence onthe tooth surface. With a simple swab and reagent that results in acolor change, bacteria on the tooth surface can be identified at highlevels. The second swab test comprises a disposable protein sampler andidentifying swab that changes color change indicator after swabbing.There is a color scale included with this swab test that helps todetermine protein levels which are a direct result of levels of bacteriain the patient's mouth. A preferred commercially available colorchanging protein swab is the Biotrace Pro-Tect® system. This is aproduct of Biotrace Limited, located in Bridgend, in the UK. Details ofthe protein swab test and procedures will be described as part of theDetailed Description of the invention that follows.

The activity potential of the bacterial biofilm can be determined withthe ATP bioluminescence. By taking a biofilm baseline reading of theATP, then having the patient rinse with a specific concentration of asugar in water solution for a specific time, then waiting a specificperiod of time and retesting. In a preferred embodiment, the sugar usedis selected from the group consisting of sucrose and glucose, and thetime period for retesting ranges from between 10 seconds and 10 minutes.The concentration of the sugar rinse used for this swab test is 0.1-40%by weight. Retesting for a second ATP level will provide a direct,calibrated, measure of the biofilm metabolic activity potential fromwhich diagnostic decisions can be determined.

Yet another swab test that is part of this invention involves a rapidculture test for the detection of Mutans streptococci and Lactobacillifrom the patient's tooth surface wherein the swab is removed from asterile package; rubbed on a tooth surface, transferred to an agar tubeselective for Mutans streptococcus, incubated at body temperature (37degrees C.) for 3-24 hours, and read for the number of colony formingunits of Mutans streptococci and Lactobacilli.

The system of the instant invention includes a diagnostic testingcomponent, a diagnostic survey questionnaire, and a plurality ofantimicrobial treatment components. Caries risk assessment and treatmentprocedures are now the standard of care in California and it may becomestandard in other locations. Details on the components, materials andmethods of the invention will be detailed shortly.

SUMMARY OF THE INVENTION

This invention provides a complete turnkey system for caries riskassessment and treatment, including a protein test, an ATP test and arapid bacterial culture test, and a plurality of rinses and educationaland diagnostic materials. The system for the detection and treatment ofthe bacterial infection that causes dental caries in a patient comprisesa disposable protein identifying swab with a color change indicator, adisposable ATP Bioluminescence sampler to swab areas of the patient'smouth, a bioluminescent light meter which measures the amount of ATPpresent in the patient's mouth, a rapid culture test for the detectionof Mutans streptococci and Lactobacilli, a diagnostic testing componentthat includes a caries risk assessment questionnaire, a treatmentcomponent that includes a therapeutic oral rinse comprising at least twocomponents, a daily treatment component selected from the groupcomprising an oral rinse and an oral spray to be used by the patientindependently, and a patient diagnostic survey questionnaire, which isassessed by a dental professional and that, with a decision tree,pinpoints any oral bacterial infection that exists in the patient thatcauses dental caries.

A preferred ATP Bioluminescence sampler to swab areas of the patient'smouth of this invention is the UltraSnap™ swab made by the HygeniaCompany. UltraSnap is a simple and effective means for sampling whichhas a self-contained ATP device to measure ATP levels and the bacteriallevels in a patient's mouth.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts the Caries Risk Assessment Form of this invention

FIG. 2 depicts the CAMBRA Decision Tree of this invention

FIG. 3 depicts the components of a kit of this invention

FIGS. 4 and 4 a shows the “SNAP-SWAB” of this invention: FIG. 4A showsthe swab being rubbed on a tooth surface and FIG. 4 shows the swabplaced in the protective swab tube after swabbing has been done

FIG. 5 shows a user whose hand is breaking the “SNAP-VALVE” at the topof the swab by bending the bulb of the swab tube

FIG. 6 shows a user shaking the swab

FIG. 7 shows the swab being placed in the ATP bioluminescence lightmeter

FIG. 8 shows the ATP screen that shows the bioluminescence light metertest results for the swab placed therein

FIG. 9 is a view of a patient's dentition

DEFINITIONS USED IN THIS INVENTION

For purposes of this invention, a dental professional can be a dentist,a dental hygienist or a certified dental assistant.

In this invention, caries and periodontal disease are the oral healthconditions that are being treated and improved by the system, methodsand kit of the present invention

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention deals with a biological approach to treatment of apatient's oral health problems. A large part of this approach involvesthe measurement of the types and amounts of bacteria present in thepatient's mouth. It is known that while numerous different bacteria playmajor roles in dental caries and periodontal disease and many have yetto be identified. Two specific bacteria have been consistentlyidentified with dental caries risk. These bacteria are Mutansstreptococci and Lactobacilli. Measurement of these bacteria in apatient's saliva enables the dental professional to treat the patientwith a goal of long-term dental health. The instant invention provides aplurality screening tests, diagnostic guidelines, professionalassessment forms, oral rinses and a daily treatment program to ensureand preserve the patient's long term oral health.

With reference to FIG. 1, a Caries Risk Assessment Form (CRAF) iscompleted by a dentist, or otherwise qualified dental professional whilea patient visits a dental office. The patient is an adult or a childover the age of six years. Caries risk assessment can be performed onchildren under the age of six years, with additional considerations.

In general, patients with high risk of caries include: those withrecurrent or residual decay, as shown by their treatment history;patients who are about to receive orthodontic care (as it is known thatorthodontic appliances and/or brackets are natural sites forcolonization of Streptococcus Mutans; patients with crown and bridgerestorations; patients with limited salivary flow (xerostomia) due tosystemic medications such as anti-hypertensive medicaments,anti-depressants, tranquilizers, antihistamines, and other drugs knownto reduce saliva flow. Also factors are certain systemic diseases suchas Sjogren's Syndrome, scleroderma, lupus, rheumatoid arthritis, or withneurological conditions such as Parkinson's Disease. Also at high riskare new patients exhibiting poor oral hygiene, poor dental knowledgeand/or poor compliance with following instructions; and patients underperiodontal care with exposed root surfaces. Age is a factor in thatpatients at peak periods for decay are often in their early teens, 20'sand over 55 years of age.

The present invention uses the CRAF of FIG. 1 to assess a patient's risklevel. The CRAF has four columns labeled 1, 2, 3 and 4. The CRAF can bea paper document and/or part of the patient's computerized dentalrecord. As seen in FIG. 1, the CRAF column 1 lists seven factorcategories in rows and a plurality of items under each category andthree columns that classify the factors into rankings of HIGH, MODERATE,and LOW for each. The factors listed in column 1 of the CRAF areselected from the group consisting of local factors, dental conditions,medical history, dietary habits, environmental issues, protectivefactors and laboratory tests.

The first category of risk factors in column 1 or the CRAF is localfactors. The local factors are the presence of dental plaque and/orcalculus. The dental professional completing the form would indicate thepresence of plaque and/or calculus by indicating if these factors arepresent or not present by using the columns headed high, moderate, andlow.

The next category of column 1 is labeled ‘dental conditions’ and lists“visible cavitation”, “cavity in last three years”, “inadequate salivaflow” exposed roots”, “deep pits/fissures”, “radiographic lesions” and“white spot lesions”, and “appliances present”

The next category in column 1 is MEDICAL HISTORY. Factors that indicatea high caries risk in this category are listed in column 2 and include“Sjogren's syndrome”, “hyposalivary meds”, and “radiation therapy”. Thenext category in column 1 includes DIETARY HISTORY and indicates incolumn 2 that a high risk is present for “>3 snacks between meals” and“regular (sugar-sweetened) soda”. The fifth category assigns a high riskfactor to the use of “recreational drugs” under the categoryENVIRONMENTAL. The sixth category of column 1 is PROTECTIVE FACTORS. Inthis category, high risk is assessed in column 2 when there is no“fluoridated water”, no “fluoridated toothpaste use”, and “inadequatesaliva flow.” The seventh category, LABORATORY TESTS in column 2,indicates the recommendation of both “saliva flow” and “Caricult rapidculture tests” for patients at high risk.

Column 2 of the CRAF of FIG. 1 represents those patients at relativelyhigh risk of caries. Typical responses that will fall into the high riskcategory are those patients having recent cavitation, inadequate salivaflow, dental appliances present, and who have at least one of the listedmedical conditions, eat sugary snacks and/or beverages, use recreationaldrugs, and are low on protective factors such as fluoridated waterand/or toothpaste.

Column 3 of the CRAF of FIG. 1 contains the responses that categorize apatient at moderate risk. These responses include localizedplaque/calculus, and “yes” responses in the areas under the DENTALCONDITIONS of “exposed roots”, “deep pits/fissures”, “radiographiclesions” and “white spot lesions”.

Regarding the risk factors under “Dietary Habits”, moderate risk cariespatients snack between meals 1-3 times and have infrequent use ofregular soda. Patients at moderate caries risk likely use no fluoridemouth rinse, no xylitol gum or mints, no chlorhexidene rinse, and nopovidone Iodine rinse. Depending upon the moderate risk patient's ATPbioluminescence Cariscreen score, they may be indicated for the Caricultrapid culture test.

Patients at low risk are addressed in Column 4 of the CRAF of FIG. 1.They have minimal or no plaque/calculus, no positive responses in theentire category of DENTAL CONDITIONS, no positive responses in theentire category of MEDICAL HISTORY, infrequent snacking between meals,no regular soda, no use of recreational drugs, and all positiveresponses in the PROTECTIVE FACTORS category.

Prior published studies of patients show that between 30% and 40% haveStreptococcus mutans infections in their oral cavities at levels above250,000 colony forming units per milliliter (cfu/ml). The level of250,000 cfu/ml is an internationally recognized standard of caries risk(see I. Zickert et al, “Effect of Caries Preventive Measures in ChildrenHighly infected with the Bacterium Streptococcus mutans, in J. OralBiol., 1982, pp. 861-868).

Typically, 10% of patients are high risk and 20% are medium risk asmeasured by the levels of Streptococcus mutans in their oral cavity.There are certain objective measures of Streptococcus mutans levelswhich are available to determine whether a patient is at high or mediumrisk of caries. Prior art testing procedures are available in themarketplace, including CARIESCREEN by APO Diagnostics Inc. or the CRTsaliva test manufactured by Ivoclar-Vivadent. Categorization of patientsinto low risk, medium risk and high risk is essential to provide theoptimal frequency of dental treatments to prevent future dental caries.This is a significant factor as those at medium risk and high risk that,if left untreated, will be at greater risk of developing symptoms(cavities) of the disease.

In addition to the necessity of objectively measuring Streptococcusmutans (MS) levels in the oral cavity, the CRAF of this inventionprovides insight into the dental and medical history of the patient, theoral hygiene habits of the patient, the age of the patient, and the typeof medications the patient is taking. It is known that the presence ofStreptococcus mutans is essential for the development of dental caries.It is also known that certain risk factors operate in determining cariesrisk.

While low risk is indicated by having less than about 250,000 cfu/mlStreptococcus mutans, one could distinguish further between a lower riskgroup having 100,000 to 250,000 cfu and a very low risk group at lessthan 100,000 cfu. Objective measurements of levels of Streptococcusmutans can be used as an indicator of an individual's likelihood ofdeveloping dental caries in the future as well as control of existingdental caries.

The relationships between bacterial counts in the oral cavity and thedevelopment of dental decay and future prognosis in a patient are stillbeing investigated. In fact, some studies are suggesting that thecut-off for high risk be lowered to 1000,000 cfu for MS. The system ofthe present invention are advantageous in that they provide both thedental treatment provider with a tool to control and reduce theincidence of dental caries and the patient do proactively play animportant, preventative role in his or her dental and periodontalhealth. The system is particularly beneficial for reducing patient riskof dental caries in the population of patients with good nutritionalhabits and good habits of dental hygiene.

Patients in a high risk group could be treated and monitored with thesystem and methods of the present invention to see if their riskgrouping drops to medium risk. Similarly those in the medium risk couldbe monitored to see if they could move to a low risk group. Thetreatment guidelines for the new risk group would then apply for thepatient. If a patient did not drop into a lower risk group then thedental treatment provider would know to continue with the currenttreatment for that risk group. This may also be a signal to the dentistthat other factors, which were not at first appreciated or realized, maybe at work. In the latter situation, the treatment methods of thepresent invention may act as an indictor of the overall oral health ofthe patient.

Each of the CRAF responses is assessed by the patient's dentist todetermine the caries risk status of each individual patient. It isespecially important to identify individuals with high Streptococcusmutans levels in their oral cavities. To measure the actual bacteriacount, the dental professional uses a method of assessing the level andtype of oral bacteria to determine the prognosis for the development ofcaries in a patient which includes the steps of

a) Swabbing an area of the patient's mouth with a disposable tool;

b) Performing a rapid culture test for the detection of Mutansstreptococcus and Lactobacilli;

c) Using a bioluminescent light meter to interpret the test results;

d) Diagnosing the likelihood for caries risk on the tested area of themouth;

e) Combining these test results with the answers to patient surveyforms, and using the decision tree shown in FIGS. 1 and 2 andexamination by dental professionals to produce a individualized cariesrisk assessment profile for the patient. The caries risk profile willthen help the dentist to prescribe a series of specific treatments forsaid patient. The rapid culture test uses an agar medium that favorsMutans streptococci, has a color change indicator, and is incubated athuman body temperature, 37 C for a period of 3-24 hours before beingread for the number of colony forming units.

The patient's risk assessment profile is done using the completed CRAFof FIG. 1, when combined with the decision tree of FIG. 2, pinpoints anyoral bacterial infection that exists in the patient that causes dentalcaries.

To do this, the dental professional starts with component A of FIG. 2,the initial swabbing of the oral cavity followed by the performance of arapid culture test. The swab used is shown and described in FIGS. 4 and4A and is more fully described below. A bioluminescent light meter(shown in FIGS. 7 and 8) is used to interpret the results of the ATPswab tests. The results of A can be either positive or negative; if theyare negative the next point on the decision tree is component B, thecaries risk assessment form, the CRAF of FIG. 1. The patient completesthe CRAF: if the results of this are negative for caries risk, thepatient is scheduled for a recall appointment. If the results ofcomponent B are positive, the patient moves on to step C which is arapid culture test for the detection of Mutans streptococci from thepatient's saliva.

Step C is another decision point on FIG. 2; if the rapid culture testproduces negative results, the patient is scheduled for a recallappointment. If the culture test is positive, the patient is now on stepD of the decision tree. Step D is the application of a therapeutic rinsefor a specified period of time determined by the dentist, usually from1-3 weeks. After this time, the patient is placed on a daily maintenancerinse, to be used independently after completing the therapeutic rinse.

After repeated use of the daily maintenance (for a usual time period ofabout 3 weeks, the is retested at the dental office and the rapidculture test of step C to assess the effectiveness of the treatment andpatient behavioral modification. This procedure is repeated until Step Cgives a negative result for the detection of Mutans streptococci.

This invention includes at least two rinses. The rinses include atreatment component that includes a short term therapeutic oral rinseand a long term maintenance treatment component that comprises a longterm maintenance rinse and an oral spray to be used by the patientindependently.

The short term therapeutic rinse of this invention is a two componentproduct. The first of the two components of the short term therapeuticrinse is comprises at least one sugar-free taste enhancing agent, atleast one solvent, at least one carrier, at least one preservative and aflavoring. More specifically, the first of the two components of thetherapeutic rinse comprises xylitol as the sweetener, water as thecarrier, Poloxamer 407 as the surfactant, flavor enhancers selected fromthe group consisting of menthol, peppermint, cranberry, cinnamon,citrus, mint oil and lemon, sodium benzoate as the preservative, andsodium fluoride for anti-cavity protection and remineralization.

Poloxaers are a non-ionic surfactants which are polyoxyethylenepolyxypropylene block copolymers. In the present invention, thepoloxamer 407 is bought from Voigt Global Distribution of Kansas City,Mo.

The second of the two components of the short term therapeutic rinsecomprises at least one antimicrobial agent, a carrier, and sufficient pHadjusters to bring the pH to a basic value higher than 7.0. Morespecifically, the second of the two components of the therapeutic rinsecomprises sodium hypochlorite as the antimicrobial agent, water as thecarrier, and sodium hydroxide as the pH adjuster.

Another rinse of this invention is the long term maintenance rinse. Itis used by the patient independently and comprises at least oneantimicrobial agent, a solvent, at least one flavoring, a preservative,at least one pH adjuster, and at least one remineralization agent. Theremineralization agent is selected from the group consisting offluoride, calcium and phosphate ions in the form of water soluble salts.

More specifically, a preferred long term maintenance rinse flavoring isxylitol, the solvent is water, the antimicrobial agents are selectedfrom the group consisting of polyphenols of white tea extract andanthocyanidins of cranberry extract, the preservative is sodiumbenzoate, the remineralization agent is sodium fluoride, and the pHadjuster is sodium bicarbonate. The pH adjuster is present to insurethat the pH of the long term maintenance rinse is higher than 7

The long term maintenance treatment of this invention may also include aspray that is used for antimicrobial treatment, acid buffering, andremineralization. A preferred oral spray comprises the flavoring ofxylitol, the solvent is water, the antimicrobial agents are selectedfrom the group consisting of polyphenols of white tea extract andanthocyanidins of cranberry extract, the preservative is sodiumbenzoate, the remineralization agents are calcium and phosphate ions,and the pH adjuster is sodium bicarbonate.

Additional products included in the system of this invention includeoral chewing substances made of natural leaf products selected from thegroup consisting of mint leaves, tea leaves, herbal leaves, tobaccoleaves, the flavoring is xylitol, the solvent is water, theantimicrobial agents are selected from the group consisting ofpolyphenols of white tea extract and anthocyanidins of cranberryextract, the preservative is sodium benzoate, the remineralization agentis selected from the group consisting of calcium and phosphate ions, andthe pH adjuster is sodium bicarbonate.

The instant invention includes a kit for patients use in conjunctionwith professional dental treatment in the control of oral bacterialinfection to prevent the occurrence of dental decay in patients. Asdepicted in FIG. 3, the kit includes

i) a first rinse that is a two-part short term therapeutic rinse 20 thatreduces Mutans streptococci and Lactobacilli levels and whose componentsare listed supra.

ii) a second long term maintenance rinse 22

iii) an oral spray that is packaged in a plastic spray bottle and thatcomprises a flavoring, a solvent, an antimicrobial agent, apreservative, a remineralization agent, and a ph adjuster.

The rinses of this invention are a large part of the uniqueness andutility of the present invention. The two-component short termtherapeutic rinse can be made using the following formula

Component One:

CAMBRA CariStat™ Treatment Oral Rinse

Component Rinse A % Wt Water 72.70 Xylitol 22.0 Mint Oil 1.0 SodiumBenzoate 2.0 Poloxamer 407 1.25 Menthol 1.0 Sodium Fluoride 0.05 TotalRinse 100In the above formulation, xylitol is a sweetener, sodium benzoate is apreservative, sodium fluoride is a decay-preventive and remineralizationagent, sodium bicarbonate is a pH buffer, menthol is a flavoring andwater is the solvent.Component Two:

Component Rinse B 6% Sodium Hypochlorite Solution 2.84 gal Water 42.6gal 18% Sodium Hydroxide Solution, added to achieve a solution pH of11.9In the above formulation, sodium hypochlorite is the antimicrobialagent, sodium hydroxide is present to keep the pH of the formula at orabove a pH value of 7 and water is the solvent.The CariStat™ maintenance rinse with Fluoride has the following formulaSingle Component Long Term Maintenance Rinse

Weight (lbs) Weight percent Xylitol 114.4 25% Water 333.9 72.95%   40gal Sodium Benzoate 9.15  2% Sodium Fluoride .228 .05%  SodiumBicarbonate to pH of 7+ Natural Flavoring (lemon) ¾ cup Color (Red,Yellow)

The ingredients listed above are present as a sweetener (xylitol), apreservative (sodium benzoate), anti-cavity/remineralization agent(sodium fluoride), pH buffer (sodium bicarbonate), solvent (water) andflavor (lemon) and color (red).

EXPERIMENTAL DATA

All patients who are treated for the prevention and treatment of dentalcaries, including risk assessment, activity level, and interventionbegin their treatment by being swabbed and categorized for caries riskbased on the following procedure:

The CariScreen™ Swab sampling device shown in FIG. 4 is a self-containedATP device for use with the CariScreen Meter used for CariesSusceptibility Testing. This system is used as a screening test for thepresence of high dental caries risk. The CariScreen Meter in conjunctionwith the CariScreen Swab measures adenosine tri-phosphate (ATP), theuniversal energy molecule found in all animal, plant, bacterial, yeast,and mold cells.

When collecting a sample, the dental professional must make sure to useaseptic techniques; care must be taken to not touch the swab or theinside of the sampling device with fingers. The patient's mouth shouldbe at rest, which in general terms means no mechanical activity,brushing, flossing, swishing, coughing, chewing, eating and the like fora period of 15-30 minutes prior to the test.

The first step of swab sampling is to remove the swab which ends in atip 32 from the swab tube 41. The swab tip 32 is rubbed on a toothsurface 40 as depicted in FIG. 4A. After swabbing, the swab 32 is putback into the swab tube 41.

Condensation may be visible on the inside of the swab tube, which isnormal. The buccal surface of a maxillary molar in the gingival thirdwithout touching the gingiva is swabbed carefully with the swab tip. Theswab tip is moved across the tooth surface three times from mesial todistal. Use the maxillary right first molar if it is present; if notpresent select the second molar or premolar to swab instead. Using thesame swab, carefully swab a maxillary incisor in the gingival third withthe same protocol: swab three times across the surface from mesial todistal being sure not to contact the gingiva. Use the maxillary rightcentral incisor if it is present; if not present select another incisorand swab it with the same protocol. A patient's dentition is shown inFIG. 9, which diagrams a mouth. The mesial, distal, buccal, lingual, andfacial areas of the mouth are shown along with some further explanatorynotes.

After swabbing the desired test area, place swab 32 back in swab tube41. The sample can be left for up to 4 hours on the cotton ball-end ofthe swab before activating the device, however once activated the samplemust be read in the CariScreen Meter within 60 seconds.

ATP is brought into contact with a sample of the swab tip 32 when a usersnaps the snap valve 36 between the bulb 34 and the swab shaft 36 asseen in FIG. 5. The unique liquid-stable luciferase/luciferin reagentcontained in the bulb 34 of CariScreen Swab sampling device 14, light isemitted in direct proportion to the amount of ATP present.

FIG. 5 depicts the activation of the device. It is activated by holdingthe swab tube 41 firmly, and using the thumb and forefinger to break thesnap valve 35 by bending the bulb 34 forward and backward. Squeeze thebulb twice expelling all liquid down the swab shaft 36. Bathe the swabbud in liquid by gently shaking for 5-10 seconds as shown in FIG. 6.

FIGS. 7 and 8 display the reading and interpretation of the results ofthe swab test. The swab 14 is inserted into a ATP bioluminescence lightmeter such as the CariScreen Swab bioluminescent light meter 12. The lidis closed and read the results by pressing “OK”. A 15-second sequencewill then commence. Results should be read within one minute ofactivation of the ATP light meter 12.

The reading will appear on the screen 38 of the ATP light meter 12 as anumber of RLUs (1-9999). This number is recorded for the patient on theCRAF form 10 Values correspond to level of risk as follows:

-   -   0-1500=low risk    -   1501-3500=moderate risk    -   3501-9999=high risk    -   There will also be an icon in the lower portion of the screen 12        indicating low, moderate, or high risk. The ATP bioluminescence        instrument manual will contain further user information and        details.        Cases:        Case 1) Patient 1 was a 48-year-old Caucasian male who does blue        collar work. He presented for oral examination and was examined        and tested for caries risk assessment. Upon screening, an ATP        Bioluminescence swab 14 was swabbed over the buccal surface of        the maxillary first molar in the gingival third three times.        After this was done, also swabbed on the labial surface of the        maxillary central incisor in the gingival third three times,        after which the swab was placed into the ATP Bioluminescence        light meter 12. The reading in relative light units (RLU) after        15 seconds was 4242 indicating this patient was potentially high        risk for dental caries. As a next step in the system, the        patient was both cultured with a rapid culture for Mutans        Streptococci and surveyed with the CRAF form 10 of FIG. 1. The        results of the culture demonstrated CFU's colony forming units        greater than 10⁵, indicating high risk. The completed CRAF form        10 also demonstrated a high risk for caries.

A diagnosis of the bacterial infection that is responsible for dentalcaries was confirmed. The patient was treated with the short termtherapeutic two-component oral rinse 20 once per day for two weeks. Thiswas followed by treatment with the long term maintenance oral rinse 22on an ongoing basis. The patient was subsequently cultured at the end ofone month and the bacterial rapid culture demonstrated fewer than 10⁵colony forming units of Mutans streptococci, indicating that theinfection had been controlled and the patient was now at low risk forthe bacterial infection responsible for dental caries. The patient wasplaced back into a normal re-care appointment schedule for regulardental check-ups, which will include routine ATP Bioluminescence swab 14screening.

2) Patient 2 was a 56-year-old Caucasian female patient who is a whitecollar professional. She presented for a routine dental re-careappointment and caries risk assessment. Upon screening with the ATPBioluminescence swab 14, which was swabbed over the buccal surface ofthe maxillary first molar in the gingival third three times, and thenalso swabbed on the labial surface of the maxillary central incisor inthe gingival third three times. The swab 14 was then placed into the ATPBioluminescence light meter 12. The reading in RLU's after 15 secondswas 321 indicating this patient was low risk for dental caries. As anext step in the system, the patient was surveyed with the CRAF RiskAssessment form 10. The results of the questionnaire indicated thepatient was low risk for dental caries. A diagnosis was confirmed thatthe patient was low risk for the bacterial infection responsible fordental caries, and the patient was placed back into the normal re-carescheduling for dental check-ups.

SCOPE OF THE INVENTION

The above presents a description of the best mode contemplated ofcarrying out the present invention, and of the manner and process ofusing it, in such full, clear, concise, and exact terms as to enable anyperson skilled in the art to which it pertains to make and use thisinvention. This invention is, however, susceptible to modifications andalternate constructions from that discussed above which are fullyequivalent. Consequently, it is not the intention to limit thisinvention to the particular embodiments disclosed. On the contrary, theintention is to cover all modifications and alternate constructionscoming within the spirit and scope of the invention as generallyexpressed by the following claims, which particularly point out anddistinctly claim the subject matter of the invention.

The invention claimed is:
 1. A kit for caries risk assessment andtreatment including a sampling and screening testing device comprising adisposable swab enclosed in a tube, said swab connected to a containerdevice holding a reagent that reacts with a sample of a biofilmcollected from a patient's mouth using the swab, said device beingmanually actuated to release the reagent upon collecting said sample,and a light meter for detecting bioluminescence that is adapted toreceive the swab after using the swab to obtain the sample and provide areading indicating caries risk, a decision tree chart for assessment bya dental professional of the answers to the patient diagnostic surveyquestionnaire, and a therapeutic agent for treating or preventingcaries.
 2. The kit of claim 1 where the therapeutic agent includes ananti-cavity remineralization agent and an antimicrobial agent.
 3. Thekit of claim 1 including a culture test for Mutans streptococci andLactobacilli.
 4. A kit for caries risk assessment and treatmentincluding a sampling and screening testing device comprising adisposable swab enclosed in a tube, said swab connected to a containerdevice holding a reagent that reacts with a sample of a biofilmcollected from a patient's mouth using the swab, said device beingmanually actuated to release the reagent upon collecting said sample,and a light meter for detecting bioluminescence that is adapted toreceive the swab after using the swab to obtain the sample and provide areading indicating caries risk, a decision tree chart for assessment bya dental professional of the answers to the patient diagnostic surveyquestionnaire, a therapeutic agent for treating or preventing cariescomprising an anti-cavity remineralization agent, and an antimicrobialagent, and a culture test for Mutans streptococci and Lactobacilli.